Alkermes Public Limited Company operates as a biopharmaceutical company worldwide. The company researches, develops, and commercializes, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. The company has a portfolio of marketed drug products and a clinical pipeline of products that address central nervous system disorders, such as schizophrenia, depression, addiction, and multiple sclerosis. Products Proprietary Products The company develops and commercializes in the U.S. products designed to address the unmet needs of patients suffering from addiction and schizophrenia. ARISTADA ARISTADA (aripiprazole lauroxil) is an extended-release injectable suspension for the treatment of schizophrenia, which was approved by the U.S. Food and Drug Administration, and commercially launched by the company, in October 2015. ARISTADA is the first of the company’s products to utilize its proprietary LinkeRx technology. ARISTADA is a prodrug; once in the body, ARISTADA is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. ARISTADA is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an intramuscular injection. ARISTADA possesses three dosing options (441 mg, 662 mg, and 882 mg) packaged in a ready-to-use, pre-filled product format. The company develops, manufactures, and commercializes ARISTADA in the U.S. VIVITROL VIVITROL (naltrexone for extended-release injectable suspension) is the once-monthly, non-addictive, injectable medication approved in the U.S., Russia, and certain of the Commonwealth of Independent States for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL uses the company’s polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through one injection every four weeks. The company develops, manufactures, and commercializes VIVITROL in the U.S., and Cilag GmbH International commercializes VIVITROL in Russia and certain countries of the Commonwealth of Independent States. Products Using Proprietary Technologies The company has granted licenses under its proprietary technologies to enable third parties to develop, commercialize, and in some cases, manufacture products for which the company receives royalties and/or manufacturing revenues. Such arrangements include the following: INVEGA SUSTENNA/XEPLION, INVEGA TRINZA and RISPERDAL CONSTA INVEGA SUSTENNA/XEPLION (paliperidone palmitate) and INVEGA TRINZA (paliperidone palmitate) and RISPERDAL CONSTA (risperidone long-acting injection) are long-acting atypical antipsychotics that incorporate the company’s proprietary technologies and are owned and commercialized worldwide by Janssen (Janssen Pharmaceutica Inc.; Janssen Pharmaceutica International, a division of Cilag International AG, and their affiliates; and Janssen Pharmaceutica N.V.). INVEGA SUSTENNA is approved in the U.S. for the treatment of schizophrenia and for the treatment of schizoaffective disorder as either a monotherapy or adjunctive therapy. Paliperidone palmitate extended-release injectable suspension is approved in the European Union and other countries outside of the U.S. for the treatment of schizophrenia, and is marketed and sold under the trade name XEPLION. INVEGA SUSTENNA/XEPLION uses the company’s nanoparticle injectable extended-release technology to increase the rate of dissolution and enable the formulation of an aqueous suspension for once-monthly intramuscular administration. INVEGA SUSTENNA/XEPLION is manufactured by Janssen. INVEGA TRINZA is an atypical antipsychotic injection for the treatment of schizophrenia used in people who have been treated with INVEGA SUSTENNA for approximately four months. INVEGA TRINZA, the first schizophrenia treatment to be taken once every three months, became commercially available in the U.S
alkermes plc (ALKS:NASDAQ GS)
1 Burlington Road
Dublin, D04 C5Y6
Phone: 353 1 772 8000
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